Effect of SGLT2 inhibitor Dapagliflozin on muscle strength and function in elderly patients with diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in muscle strength and muscle function
研究概览
简要总结
The study is planned to evaluate the effect of SGLT2 inhibitor (Dapagliflozin) on muscle strength and function over a short-term use of 8weeks. Type 2 diabetes patients aged 60 and above will be recruited if their hBA1C is below 8 and not on insulin or SGLT2inhibitor therapy. Patients with other comorbidities with significant effect on muscle strength/function shall be excluded.Following recruitment their muscle strength and function are assessed with simple bedside tests. The, tablet dapagliflozin 10mg (generic) shall be introduced as a part of standard of care therapy. Patients shall be recalled at week 4 for general assessment and note for adverse events if any. At week 8, the same baseline tests for muscle strength and function shall be reperformed and changes if any, noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with type 2 diabetes with age above 60 years irrespective of diabetes duration and HbA1C below 8.
排除标准
- •Already on SGLT2 inhibitors or insulin therapy,Established CKD/CVA/CAD/CLD,Immobility/restricted mobility due to any reason, Intake of drugs -steroids including anabolic ones, oestrogen, testosterone.
结局指标
主要结局
Change in muscle strength and muscle function
时间窗: Following oral dapagliflozin 10mg therapy for 8 weeks
次要结局
- Effect of Glycemic change with dapagliflozin and its effect on muscle strength and muscle function(change over 8 weeks)
研究者
Dr VK Sashindran
K.S.Hegde Medical College